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MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal into the CSF

Phase 2

Amyotrophic Lateral Sclerosis | Monoclonal antibody | Neurology |Brainstorm Cell Therapeutics Inc.|Last Updated: Mar 8, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal into the CSF · 1 trial · 1 indication

Phase 2 1
NCT01777646Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis
COMPLETED14 Analytics
PHASE2COMPLETED
Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis
NCT0177764614
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Study Endpoints

Primary Endpoints

Safety evaluation and tolerability of a single treatment administration in an escalating-dose of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF)
At baseline and up to 6 month following treatment administration

Secondary Endpoints

Changes in the progression rate of the disease as evidenced by changes in the ALS functional rating scale
At baseline and up to 6 month following treatment administration
Changes in muscle strength grading (MVIC) by muscle chart
At baseline and up to 6 month following treatment administration
Changes in muscle bulk estimated by MRI of the upper and lower extremities
At baseline and up to 6 month following treatment administration
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MSC-NTFEXPERIMENTAL -

Interventions

NameTypeDescription
MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal injection into the CSFBIOLOGICAL -
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patient must fulfill El Escorial criteria (APPENDIX 2) for definite or probable ALS (sporadic and not familial) 2. Participants, either men or non pregnant women are between 20 and 75 years of age. 3. The patient is mentally intact and psychologically stable 4. Patients will ...

Countries:Israel
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